FDA.reportPublic FDA data

MAHURKAR

Primary DI
10884521004870
Brand
MAHURKAR
Company
Covidien LP
Model
8813816005
Catalog number
8813816005
Device description
Acute Dual Lumen Catheter,Straight Extensions with 2 Sealing Caps,11.5 Fr/Ch (3.8 mm) x 13.5 cm
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943349000MAHURKAR DUAL LUMEN CATHETERQuinton, Inc.1995-03-22FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521004870PackageGS15In Commercial Distribution
20884521004877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452100487010884521004870
2088452100487720884521004877

GMDN Terms#

Term, Definition table
TermDefinition
Ostomy bag press plate/beltA non-sterile fastening device consisting of a plate and belt designed to apply pressure to stabilize an ostomy bag (receptacle that collects bodily waste through a stoma) to a patient''s body. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge11.5French
Length13.5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00; Avoid direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10884521102163Vascufil88864788-05V2015-08-31
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29

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